Newsletter | May 30, 2025

05.30.25 -- EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety

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FEATURED EDITORIAL

EMA Issues Paper On Qualifying Non-Mutagenic Impurities

There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation and how to make assessments.

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